Ideas and Insight supporting all stages of Drug Discovery & Development

Reducing Adverse Event Risk

In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined during drug development, as part of an adequate assessment of the drug’s safety and effectiveness.”

And yet drug-drug interactions (DDIs) still account for 3-5% of all reported adverse drug reactions. And the incidence is increasing because patients are being prescribed more drugs, so their chances of taking a combination of drugs are higher. That’s why identifying potential DDIs and assessing their risk is a priority for pharmaceutical manufacturers and regulatory authorities.

Fortunately, PharmaPendium’s Drug-Drug Interaction Risk Calculator (DDIRC) is fully compliant with the FDA’s 2012 draft guidance for drug interaction studies. As a mechanistic static model calculator, the DDRIC can be used early in drug development. It also provides important insight into later stages of development when more parameters are known. Thanks to clear visual output data, the DDIRC makes it easy to see drugs with a high risk of interaction, even when hundreds of drugs are under consideration.

One of the advantages of the Drug–Drug Interaction Risk Calculator is that it provides unique and actionable insights into the behavior of drugs in humans. In all applications at this global biopharmaceutical group, it has helped to inform decisions that have saved the company time, money and resources, and most importantly, have reduced the risk of adverse events caused by drug–drug interactions.